| Primary Device ID | 07630345748218 |
| NIH Device Record Key | e76f74b5-9904-4801-8e29-c7082262a3c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SportsMed Instruments |
| Version Model Number | 05.05.10.0161 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630345748218 [Primary] |
| NBH | Accessories, Arthroscopic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-03 |
| Device Publish Date | 2022-04-25 |
| 07630971292161 | Ligament reconstruction wires kit |
| 07630971292154 | M-ARS ACL wires kit |
| 07630345752741 | Low Profile Reamer Ø12mm STERILE |
| 07630345752734 | Low Profile Reamer Ø11.5mm STERILE |
| 07630345752727 | Low Profile Reamer Ø11mm STERILE |
| 07630345752710 | Low Profile Reamer Ø10.5mm STERILE |
| 07630345752703 | Low Profile Reamer Ø10mm STERILE |
| 07630345752697 | Low Profile Reamer Ø9.5mm STERILE |
| 07630345752680 | Low Profile Reamer Ø9mm STERILE |
| 07630345752673 | Low Profile Reamer Ø8.5mm STERILE |
| 07630345752666 | Low Profile Reamer Ø8mm STERILE |
| 07630345752659 | Low Profile Reamer Ø7.5mm STERILE |
| 07630345752642 | Low Profile Reamer Ø7mm STERILE |
| 07630345752635 | Low Profile Reamer Ø6.5mm STERILE |
| 07630345752628 | Low Profile Reamer Ø6mm STERILE |
| 07630345752611 | Low Profile Reamer Ø5.5mm STERILE |
| 07630345752604 | Low Profile Reamer Ø5mm STERILE |
| 07630345752598 | Low Profile Reamer Ø4.5mm STERILE |
| 07630345748362 | Cannulated tibial Reamer Ø12 mm - STERILE |
| 07630345748355 | Cannulated tibial Reamer Ø11 mm - STERILE |
| 07630345748348 | Cannulated tibial Reamer Ø10 mm - STERILE |
| 07630345748331 | Cannulated tibial Reamer Ø9 mm - STERILE |
| 07630345748324 | Cannulated tibial Reamer Ø8 mm - STERILE |
| 07630345748317 | Cannulated tibial Reamer Ø7 mm - STERILE |
| 07630345748300 | Cannulated tibial Reamer Ø6 mm - STERILE |
| 07630345748294 | Bone Drill Ø4.5 L260 - STERILE |
| 07630345748287 | Bone Drill Ø4.5 L230 - STERILE |
| 07630345748270 | Acorn Reamer Ø 12 L195 - STERILE |
| 07630345748263 | Acorn Reamer Ø 11.5 L195 - STERILE |
| 07630345748256 | Acorn Reamer Ø 11 L195 - STERILE |
| 07630345748249 | Acorn Reamer Ø 10.5 L195 - STERILE |
| 07630345748232 | Acorn Reamer Ø 10 L195 - STERILE |
| 07630345748225 | Acorn Reamer Ø 9.5 L195 - STERILE |
| 07630345748218 | Acorn Reamer Ø 9 L195 - STERILE |
| 07630345748201 | Acorn Reamer Ø 8.5 L195 - STERILE |
| 07630345748195 | Acorn Reamer Ø 8 L195 - STERILE |
| 07630345748188 | Acorn Reamer Ø 7.5 L195 - STERILE |
| 07630345748171 | Acorn Reamer Ø 7 L195 - STERILE |
| 07630345748164 | Acorn Reamer Ø 6.5 L195 - STERILE |
| 07630345748157 | Acorn Reamer Ø 6 L195 - STERILE |
| 07630345748140 | Acorn Reamer Ø 5.5 L195 - STERILE |
| 07630345748133 | Acorn Reamer Ø 5 L195 - STERILE |
| 07630345748126 | Acorn Reamer Ø 4.5 L195 - STERILE |
| 07630345748119 | M-ARS Acorn Reamer Ø 4.5 - STERILE |
| 07630345747587 | Ligament reconstruction wires kit (1x) |
| 07630345747570 | M-ARS ACL wires kit (1x) |
| 07630542725920 | Quick Connect Bone Drill Ø4.5 Long - sterile |
| 07630542725913 | Quick Connect Bone Drill Ø4.5 Short - sterile |
| 07630542725906 | Quick Connect Bone Drill Ø4.5 Long |
| 07630542725890 | Quick Connect Bone Drill Ø4.5 Short |